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Vault Snack #30 – Additional Curve Fits for Plotting and Analysing Assay Data in CDD Vault

Collaborative Drug

Some of the most recent enhancements to the CDD Vault Curves add-on include the Pharmacokinetic (PK) IV and Oral curve fits. If you are not yet subscribed to Curves, please contact your CDD Account Manager, or CDD Support , to discuss enabling these features in your Vault.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Investigational products with novel mechanisms of action are also assessed for safety in unique ways, creating complexities that can be more dynamically and effectively monitored using biologically relevant biomarkers. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Conclusion The regulatory environment in Japan for generic drug development is complex and evolving.

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Shifting the ADC focus from antibody to payload

Drug Target Review

And in the small molecule space, it’s about overcoming pharmacokinetic factors and formulation issues.” Greally explains that this iterative approach allows for more rigorous evaluation of ADC candidates, particularly in relation to pharmacokinetics and in vivo performance.

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Toxicology transformed: Why accuracy now leads the way

Drug Target Review

Purity and radioactive enrichment are key factors in ensuring the IS aligns with product specifications. For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines.

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Biogen Advances Investigational SMA Therapy to Registrational Trials After Positive Phase 1 Data

The Pharma Data

The goal is to boost SMN protein production more effectively and offer a more convenient, once-a-year dosing schedule , thereby improving long-term disease management and patient compliance. The study included two parts: Part A : A randomized, placebo-controlled segment in healthy adult male volunteers.

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Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. ” – Dr.